Effects of Spinal Cord Stimulation on Gait in Patients With Parkinson´s Disease
NCT ID: NCT05148468
Last Updated: 2024-05-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
NA
8 participants
INTERVENTIONAL
2021-11-30
2024-03-01
Brief Summary
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1. Produce stronger evidence on SCS efficacy for PD in regards to gait, motor scores and quality of life measures by incorporating subthreshold in a randomized cross over placebo-controlled study with a large sample.
2. Identify predictors of good response to SCS therapy by performing trans spinal magnetic stimulation (TSMS) before SCS implant and correlating the response to SCS to that of the noninvasive TSMS.
3. Better provide biomarkers of SCS therapy through functional magnetic resonance imaging and electroencephalographic mapping.
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Detailed Description
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Consensus on tonic SCS efficacy is hampered mostly due to small samples and lack of randomized controlled trials so far, and the impossibility of subject blinding due to standard stimulation settings using currents over the paresthesia inducing threshold. Some small studies already attempted subthreshold blinding and all resulted in non significant results, however with no important difference when switching to suprathreshold settings, thus raising the possibility of non responder subjects or inefficient therapy and calling for additional exploration. The investigators aim to explore the feasibility of a placebo controlled trial using subthreshold stimulation with a larger sample and produce stronger evidence on SCS efficacy for PD.
Additionally, the possibility of non responder subjects will be explored by correlating the degree of response to SCS to patient demographic characteristics including age, PD severity and cognition, gait characteristics and the degree of response to trans spinal magnetic stimulation (TSMS), a non invasive magnetic stimulation of upper thoracic spinal region, aiming to identify prognostic factors for the therapy.
Finally, functional magnetic resonance imaging and electroencephalographic mapping will be performed in order to identify biomarkers of SCS therapy.
Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
QUADRUPLE
Study Groups
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Active stimulation
During active stimulation phase, patients will receive through the spinal cord stimulator active tonic stimulation with amplitude set to 90% of paresthesia inducing threshold, therefore allowing blinding. Patients will be evaluated after a three week wash out period with no stimulation and after three weeks of continuous active stimulation.
Active spinal cord stimulation
Spinal cord stimulation is accomplished with surgically implanted epidural leads at Th3 - Th4 levels and a pulse generator implanted in subcutaneous fat. During active stimulation amplitude will be set to 90% paresthesia inducing threshold.
Sham stimulation
During sham stimulation phase, patients will receive through the spinal cord stimulator a zero amplitude stimulation, therefore having no electrical current passing through epidural leads but with the program status still displayed as "on" if checked with patient's personal controller. Patients will be evaluated after a three week wash out period with no stimulation and after three weeks of continuous sham stimulation.
Sham spinal cord stimulation
Spinal cord stimulation is accomplished with surgically implanted epidural leads at Th3 - Th4 levels and a pulse generator implanted in subcutaneous fat. During sham stimulation amplitude will be set to zero.
Interventions
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Active spinal cord stimulation
Spinal cord stimulation is accomplished with surgically implanted epidural leads at Th3 - Th4 levels and a pulse generator implanted in subcutaneous fat. During active stimulation amplitude will be set to 90% paresthesia inducing threshold.
Sham spinal cord stimulation
Spinal cord stimulation is accomplished with surgically implanted epidural leads at Th3 - Th4 levels and a pulse generator implanted in subcutaneous fat. During sham stimulation amplitude will be set to zero.
Eligibility Criteria
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Inclusion Criteria
* Main complaint of balance or freezing of gait
* Score of 2 or more on subitem 3.11 of the MDS UPDRS scale concerning Freezing of Gait severity.
* Capable of informed consent
Exclusion Criteria
* Uncontrolled or serious comorbidities such as uncontrolled diabetes mellitus, renal disease, anticoagulation, immunosuppression or other medical conditions that present a contraindication for SCS surgery
* Psychosis, uncontrolled depression (BDI \>14) or anxiety disorder (BAI \>14)
21 Years
80 Years
ALL
No
Sponsors
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University of Sao Paulo General Hospital
OTHER
Responsible Party
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Locations
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Hospital das Clínicas da Faculdade de Medicina da USP
São Paulo, São Paulo, Brazil
Countries
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References
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Agari T, Date I. Spinal cord stimulation for the treatment of abnormal posture and gait disorder in patients with Parkinson's disease. Neurol Med Chir (Tokyo). 2012;52(7):470-4. doi: 10.2176/nmc.52.470.
Fuentes R, Petersson P, Nicolelis MA. Restoration of locomotive function in Parkinson's disease by spinal cord stimulation: mechanistic approach. Eur J Neurosci. 2010 Oct;32(7):1100-8. doi: 10.1111/j.1460-9568.2010.07417.x.
de Andrade EM, Ghilardi MG, Cury RG, Barbosa ER, Fuentes R, Teixeira MJ, Fonoff ET. Spinal cord stimulation for Parkinson's disease: a systematic review. Neurosurg Rev. 2016 Jan;39(1):27-35; discussion 35. doi: 10.1007/s10143-015-0651-1. Epub 2015 Jul 30.
Fuentes R, Petersson P, Siesser WB, Caron MG, Nicolelis MA. Spinal cord stimulation restores locomotion in animal models of Parkinson's disease. Science. 2009 Mar 20;323(5921):1578-82. doi: 10.1126/science.1164901.
Thevathasan W, Mazzone P, Jha A, Djamshidian A, Dileone M, Di Lazzaro V, Brown P. Spinal cord stimulation failed to relieve akinesia or restore locomotion in Parkinson disease. Neurology. 2010 Apr 20;74(16):1325-7. doi: 10.1212/WNL.0b013e3181d9ed58. No abstract available.
Fenelon G, Goujon C, Gurruchaga JM, Cesaro P, Jarraya B, Palfi S, Lefaucheur JP. Spinal cord stimulation for chronic pain improved motor function in a patient with Parkinson's disease. Parkinsonism Relat Disord. 2012 Feb;18(2):213-4. doi: 10.1016/j.parkreldis.2011.07.015. Epub 2011 Aug 23. No abstract available.
Santana MB, Halje P, Simplicio H, Richter U, Freire MAM, Petersson P, Fuentes R, Nicolelis MAL. Spinal cord stimulation alleviates motor deficits in a primate model of Parkinson disease. Neuron. 2014 Nov 19;84(4):716-722. doi: 10.1016/j.neuron.2014.08.061. Epub 2014 Oct 30.
Pinto de Souza C, Hamani C, Oliveira Souza C, Lopez Contreras WO, Dos Santos Ghilardi MG, Cury RG, Reis Barbosa E, Jacobsen Teixeira M, Talamoni Fonoff E. Spinal cord stimulation improves gait in patients with Parkinson's disease previously treated with deep brain stimulation. Mov Disord. 2017 Feb;32(2):278-282. doi: 10.1002/mds.26850. Epub 2016 Nov 10.
Akiyama H, Nukui S, Akamatu M, Hasegawa Y, Nishikido O, Inoue S. Effectiveness of spinal cord stimulation for painful camptocormia with Pisa syndrome in Parkinson's disease: a case report. BMC Neurol. 2017 Aug 3;17(1):148. doi: 10.1186/s12883-017-0926-y.
Samotus O, Parrent A, Jog M. Spinal Cord Stimulation Therapy for Gait Dysfunction in Advanced Parkinson's Disease Patients. Mov Disord. 2018 May;33(5):783-792. doi: 10.1002/mds.27299. Epub 2018 Feb 14.
de Lima-Pardini AC, Coelho DB, Souza CP, Souza CO, Ghilardi MGDS, Garcia T, Voos M, Milosevic M, Hamani C, Teixeira LA, Fonoff ET. Effects of spinal cord stimulation on postural control in Parkinson's disease patients with freezing of gait. Elife. 2018 Aug 2;7:e37727. doi: 10.7554/eLife.37727.
Kobayashi R, Kenji S, Taketomi A, Murakami H, Ono K, Otake H. New mode of burst spinal cord stimulation improved mental status as well as motor function in a patient with Parkinson's disease. Parkinsonism Relat Disord. 2018 Dec;57:82-83. doi: 10.1016/j.parkreldis.2018.07.002. Epub 2018 Jul 6.
Mazzone P, Viselli F, Ferraina S, Giamundo M, Marano M, Paoloni M, Masedu F, Capozzo A, Scarnati E. High Cervical Spinal Cord Stimulation: A One Year Follow-Up Study on Motor and Non-Motor Functions in Parkinson's Disease. Brain Sci. 2019 Apr 3;9(4):78. doi: 10.3390/brainsci9040078.
Hubsch C, D'Hardemare V, Ben Maacha M, Ziegler M, Patte-Karsenti N, Thiebaut JB, Gout O, Brandel JP. Tonic spinal cord stimulation as therapeutic option in Parkinson disease with axial symptoms: Effects on walking and quality of life. Parkinsonism Relat Disord. 2019 Jun;63:235-237. doi: 10.1016/j.parkreldis.2019.02.044. Epub 2019 Mar 2.
Chakravarthy KV, Chaturvedi R, Agari T, Iwamuro H, Reddy R, Matsui A. Single arm prospective multicenter case series on the use of burst stimulation to improve pain and motor symptoms in Parkinson's disease. Bioelectron Med. 2020 Sep 28;6:18. doi: 10.1186/s42234-020-00055-3. eCollection 2020.
Lai Y, Pan Y, Wang L, Zhang C, Sun B, Li D. Spinal Cord Stimulation with Surgical Lead Improves Pain and Gait in Parkinson's Disease after a Dislocation of Percutaneous Lead: A Case Report. Stereotact Funct Neurosurg. 2020;98(2):104-109. doi: 10.1159/000505707. Epub 2020 Feb 25.
Prasad S, Aguirre-Padilla DH, Poon YY, Kalsi-Ryan S, Lozano AM, Fasano A. Spinal Cord Stimulation for Very Advanced Parkinson's Disease: A 1-Year Prospective Trial. Mov Disord. 2020 Jun;35(6):1082-1083. doi: 10.1002/mds.28065. Epub 2020 Apr 20. No abstract available.
Cury RG, Carra RB, Capato TTC, Teixeira MJ, Barbosa ER. Spinal Cord Stimulation for Parkinson's Disease: Dynamic Habituation as a Mechanism of Failure? Mov Disord. 2020 Oct;35(10):1882-1883. doi: 10.1002/mds.28271. No abstract available.
Samotus O, Parrent A, Jog M. Long-term update of the effect of spinal cord stimulation in advanced Parkinson's disease patients. Brain Stimul. 2020 Sep-Oct;13(5):1196-1197. doi: 10.1016/j.brs.2020.06.004. Epub 2020 Jun 3. No abstract available.
Reis Menezes J, Bernhart Carra R, Aline Nunes G, da Silva Simoes J, Jacobsen Teixeira M, Paiva Duarte K, Ciampi de Andrade D, Barbosa ER, Antonio Marcolin M, Cury RG. Transcutaneous magnetic spinal cord stimulation for freezing of gait in Parkinson's disease. J Clin Neurosci. 2020 Nov;81:306-309. doi: 10.1016/j.jocn.2020.10.001. Epub 2020 Oct 20.
Other Identifiers
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SCSPDgait
Identifier Type: -
Identifier Source: org_study_id
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